Federal Register :: Microbiology Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management, To Be Renamed Quantitative Cytomegalovirus Nucleic Acid Tests for Transplant Patient Management

Federal Register :: Microbiology Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management, To Be Renamed Quantitative Cytomegalovirus Nucleic Acid Tests for Transplant Patient Management

FDA Issues Proposed Order to Reclassify Certain Cytomegalovirus (CMV) Quantitative Tests

Today, the U.S. Food and Drug Administration (FDA) issued this proposed order: Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management, To Be Renamed Quantitative Cytomegalovirus Nucleic Acid Tests for Transplant Patient Management.

Facts about the proposed order

This proposed order, when finalized, is intended to provide patients more timely access to these devices by:

• Reclassifying certain cytomegalovirus (CMV) deoxyribonucleic acid (DNA) quantitative assay devices that are used as an aid in the management of transplant recipients from class III to class II, subject to premarket notification (510(k)).
• Renaming these devices to quantitative cytomegalovirus nucleic acid tests for transplant patient management and provide special controls that, in addition to general controls, will provide a reasonable assurance of safety and effectiveness for these types of devices.

This proposed order will not impact tests used in the management of CMV in transplant recipients that are not based on the detection of CMV DNA.

Read the proposed order

Submit comments on this proposed order

This proposed order will be open for public comments for 60 days at www.Regulations.gov under docket number FDA-2016-N-2880.

Questions?

If you have questions about this proposed order, contact the Division of Industry and Consumer Education.